Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus

March 7, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporine Dose Reduction With Cyclosporine Elimination in De Novo Renal Allograft Recipients Receiving Rapamune.

Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80730-150
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21041-030
      • Rio de Janeiro, RJ, Brazil, 21941-590
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
      • Porto Alegre, RS, Brazil, 90020-090
      • Ribeirao Preto, RS, Brazil, 14048-900
    • SP
      • Sao Jose do Rio Preto, SP, Brazil, 15015-200
      • Sao Paulo, SP, Brazil, 05403-000
      • Sao Paulo, SP, Brazil, 01323-001
      • Sao Paulo, SP, Brazil, 04038-002
  • Mexico
      • Chihuahua, Mexico
      • Mexico City DF, Mexico, 14000
    • Coahuila
      • Torreon, Coahuila, Mexico, 27000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age.

Exclusion Criteria:

  • Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Calculated creatinine clearance at 12 months post transplantation for patients on therapy.

Secondary Outcome Measures

Outcome Measure
Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial Manager, For Brazil, xavierl@wyeth.com
  • Principal Investigator: Trial Manager, For Mexico, gomezlj@wyeth.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

March 8, 2011

Last Update Submitted That Met QC Criteria

March 7, 2011

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0468H1-101116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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